Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans

NCT01421979 | Completed

• 1 other identifier: ED2011
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to examine the safety and the effects of EDs at high doses, either alone or in combination with other risk factors such as alcohol intake, physical exercise and sleep deprivation, on cardiovascular markers and subjective health.

Conditions

Cardiovascular Risk

Outcome Measures

Primary Outcomes (1)

• Heart-rate-variability (HRV)

  during 24 hours

Study Arms (2)

exposure under sleep deprivation

EXPERIMENTAL

Examination of the effects of EDs in combination with alcohol consumption and sleep deprivation.

Dietary Supplement: Energy Drink, Taurine, Caffeine

Exercise after consumption

EXPERIMENTAL

Examination of the effects of EDs in combination with alcohol consumption and exercise.

Dietary Supplement: Energy Drink, Taurine, Caffeine

Interventions

Energy Drink, Taurine, Caffeine DIETARY_SUPPLEMENT

Exercise after consumption; exposure under sleep deprivation

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• written informed consent
• healthy (no acute or chronic desease)
• BMI 20,0 - 25,9 kg/m2
• moderate and non-regular consumption of alcohol, EDs and coffee

You may not qualify if:

• pregnancy
• regular medication (oral contraceptives permitted)
• hypertension and other deseases of the cardiovascular system
• liver-deseases
• psychiatric deseases
• epilepsy
• other relevant deseases
• (former) alcoholics
• non-compliance to the study-protocol
• simultaneous participation in another clinical trial
• retraction of the written informed consent

Sponsors & Collaborators

• University of Hohenheim: lead

Study Sites (1)

University of Hohenheim

Stuttgart, Baden-Wurttemberg, 70593, Germany

Location

Related Publications (1)

• Basrai M, Schweinlin A, Menzel J, Mielke H, Weikert C, Dusemund B, Putze K, Watzl B, Lampen A, Bischoff SC. Energy Drinks Induce Acute Cardiovascular and Metabolic Changes Pointing to Potential Risks for Young Adults: A Randomized Controlled Trial. J Nutr. 2019 Mar 1;149(3):441-450. doi: 10.1093/jn/nxy303.

  PMID: 30805607 DERIVED

MeSH Terms

Interventions

Energy Drinks; Taurine; Caffeine

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2011
• First Posted: August 23, 2011
• Study Start: April 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 5, 2015

Record last verified: 2015-02

Locations

DE (1)